Delivery system having stent retention structure

ABSTRACT

A drainage stent delivery system including an elongate shaft of a medial device, a drainage catheter or stent, and an interference fit member for selectively coupling the drainage stent to the elongate shaft. The drainage stent is selectively coupled to a distal portion of the elongate shaft by an interference fit between the interference fit member and the drainage stent such that axial movement of the elongate shaft relative to the drainage stent moves the interference fit member from a first position in which the interference fit member is engaged with the drainage stent and forms an interference fit with the drainage stent to a second position in which the interference fit member is disengaged from the drainage stent.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/357,742, filed Jun. 23, 2010, the entire disclosure of which isincorporated herein by reference.

TECHNICAL FIELD

The disclosure is directed to a retention structure of a medical device.More particularly, the disclosure is directed to a stent retentionstructure for selectively securing a stent to a shaft of a stentdelivery system. Specifically, the disclosure is directed to a retentionstructure for selectively securing a drainage stent to a catheter shaftof a drainage stent delivery system.

BACKGROUND

Medical devices, such as catheters, are widely used in various medicalprocedures to access remote anatomical locations and/or deploytherapeutic devices. One exemplary catheter system is a drainage stentdelivery system configured to deliver a drainage stent (e.g., a drainagecatheter) to a body lumen, such as a lumen of the biliary tree or aureter. It may be desirable to releasably connect the drainage stent tothe delivery system in order to provide the medical personnel withcontrol over positioning and deployment of the drainage catheter in abody lumen without premature deployment of the drainage stent from thedelivery system. Some exemplary drainage stent delivery systemsincluding features for releasably connecting a drainage stent to adelivery system are disclosed in U.S. Pat. Nos. 5,921,952 and 6,562,024,the disclosures of which are incorporated herein by reference. Forinstance, a releasable connecting feature in the form of a flexiblethread or suture may be used for releasably connecting the drainagestent to a shaft of the drainage stent delivery system.

However, a need remains to provide alternative embodiments of aretention system to releasably secure a stent, such as a vascular stentor a drainage stent, or other endoprosthesis to a stent delivery system,such as a vascular stent or drainage stent delivery system, which allowscontrolled positioning and deployment of the stent in a body lumen.

SUMMARY

The disclosure is directed to several alternative designs andconfigurations of medical device structures and assemblies including aretention structure for selectively securing a stent to a deliverysystem.

Accordingly, one illustrative embodiment is a stent delivery systemcomprising an elongate shaft of a medical device, a tubular stentpositioned on and surrounding a distal portion of the elongate shaft,and an interference fit member positioned on the elongate shaft andconfigured to cooperate with the tubular stent to form an interferencefit therebetween. Axial movement of the elongate shaft relative to thetubular stent moves the interference fit member from a first position inwhich the interference fit member is positioned within the lumen of thetubular stent and forms an interference fit with the tubular stent to asecond position in which the interference fit member is positionedexterior of the lumen of the tubular stent.

Another illustrative embodiment is a drainage stent delivery systemincluding a drainage stent including a generally non-expandable tubularmember having a proximal end, a distal end and a central longitudinalaxis. The drainage stent delivery system also includes an elongate shaftextending distally from a handle assembly to a location distal of theproximal end of the drainage stent. The elongate shaft includes aportion configured to form an interference fit with the drainage stent.The elongate shaft is longitudinally moveable relative to the drainagestent to effect disengagement of the drainage stent from the portion ofthe elongate shaft configured to form an interference fit with thedrainage stent.

Yet another illustrative embodiment is a method of selectively releasinga stent from an elongate shaft of a medical device. The method includespositioning a tubular stent removably coupled to a distal portion of anelongate shaft of a medical device at a target location of an anatomy.The tubular stent is removably coupled to the distal portion of theelongate shaft by an interference fit between the tubular stent and aninterference fit portion of the elongate shaft. The elongate shaft maybe moved in an axial direction relative to the tubular stent todisengage the tubular stent from the interference fit portion of theelongate shaft.

The above summary of some example embodiments is not intended todescribe each disclosed embodiment or every implementation of theinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more completely understood in consideration of thefollowing detailed description of various embodiments in connection withthe accompanying drawings, in which:

FIG. 1 is a plan view of an exemplary drainage stent delivery system;

FIG. 2 is a longitudinal cross-sectional view of the drainage stentdelivery system of FIG. 1;

FIGS. 3A and 3B are longitudinal cross-sectional views illustrating thefunctionality of an exemplary retention structure for selectivelycoupling a stent to an elongate shaft of a delivery system;

FIGS. 4A and 4B are longitudinal cross-sectional views illustrating thefunctionality of another retention structure for selectively coupling astent to an elongate shaft of a delivery system;

FIGS. 5A and 5B are longitudinal cross-sectional views illustrating thefunctionality of another retention structure for selectively coupling astent to an elongate shaft of a delivery system;

FIGS. 6A-6C are longitudinal cross-sectional views illustrating thefunctionality of another retention structure for selectively coupling astent to an elongate shaft of a delivery system;

FIG. 7A is a longitudinal cross-sectional view illustrating one possibleconfiguration of an interference fit member; and

FIGS. 7B-7D are cross-sectional views illustrating possibleconfigurations of an interference fit member engaged with a drainagestent.

While the invention is amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and will be described in detail. It should be understood,however, that the intention is not to limit aspects of the invention tothe particular embodiments described. On the contrary, the intention isto cover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about”, whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (i.e., having the same function orresult). In many instances, the term “about” may be indicative asincluding numbers that are rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4,and 5).

Although some suitable dimensions, ranges and/or values pertaining tovarious components, features and/or specifications are disclosed, one ofskill in the art, incited by the present disclosure, would understanddesired dimensions, ranges and/or values may deviate from thoseexpressly disclosed.

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise.

As used in this specification and the appended claims, the term“proximal” refers to a direction that is generally toward a physicianduring a medical procedure, while the term “distal” refers to adirection that is generally toward a target site within a patient'sanatomy during a medical procedure.

As used in this specification and the appended claims, the term “bodylumen” means any body passage cavity that conducts fluid, including butnot limited to biliary ducts, pancreatic ducts, ureteral passages,esophagus, and blood vessels such as those of the human vasculaturesystem.

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The detailed description and the drawings, which are notnecessarily to scale, depict illustrative embodiments and are notintended to limit the scope of the invention. The illustrativeembodiments depicted are intended only as exemplary. Selected featuresof any illustrative embodiment may be incorporated into an additionalembodiment unless clearly stated to the contrary.

Referring now to FIGS. 1 and 2, there is shown an exemplary medicaldevice, illustrated as a drainage stent delivery system 10 fordelivering a drainage catheter or stent 20 to an anatomical location,such as in a lumen of the biliary tree or a ureter. The drainage stent20 may be used to bypass or drain an obstructed lumen and can beconfigured for long-term positioning within the lumen. The drainagestent 20 may be an elongate tubular member which is generally notexpandable. The drainage stent 20 may have a proximal end 44, a distalend 46 and a lumen 48 extending through the drainage stent 20 from theproximal end 44 to the distal end 46. In some embodiments, the drainagestent 20 may include one or more, or a plurality of barbs 21, or otherretention features that may help prevent migration of the drainage stent20 when positioned in a body lumen. The illustrated drainage stent 20includes a proximal barb 21 a and a distal barb 21 b. It should beunderstood that the terms “drainage catheter” and “drainage stent” canbe used interchangeably with reference to these applications.

The drainage stent delivery system 10 is designed for use with aconventional guidewire 2 and may include a drainage stent 20, a guidecatheter 12, a push catheter 14, and a handle assembly 16. The guidewire2 may extend into a lumen 22 of the guide catheter 12 through a distalguidewire port 24 and out a proximal guidewire port 26 in a sidewall ofthe push catheter 14, providing the drainage stent delivery system 10with single-operator-exchange (SOE) capabilities.

The guide catheter 12 may be slidably disposed in the lumen 28 of thepush catheter 14 and extend distally from the distal end 30 of the pushcatheter 14. The guide catheter 12 may extend through the drainage stent20 to a location distal of the drainage stent 20. In some embodiments, adistal portion of the push catheter 14, or a component thereof, mayextend into the lumen of the drainage stent 20. In some instances, theproximal end of the drainage stent 20 may abut and/or face a distal endor rim 30 of the push catheter 14, or a component thereof, while adistal portion or component of the push catheter 14 extends into thelumen of the drainage stent 20. In other embodiments, the push catheter14, or a component thereof, may extend over the drainage stent 20,surrounding a portion of the drainage stent 20.

The drainage stent delivery system 10 may include a means for releasablyconnecting the drainage stent 20 to an elongate shaft of the drainagestent delivery system 10, such as the guide catheter 12 or the pushcatheter 14 of the drainage stent delivery system 10. When the drainagestent 20 has been properly placed, the drainage stent 20 may bedisconnected from the drainage stent delivery system 10 such that thedrainage stent 20 remains in the lumen when the guide catheter 12 and/orthe push catheter 14 are withdrawn. Some exemplary retention mechanismsfor selectively coupling the drainage stent 20 to an elongate shaft ofthe drainage stent delivery system 10 are further described herein. Theretention mechanisms may be used to selectively deploy, repositionand/or retrieve the drainage stent 20 during a medical procedure.

The proximal end 32 of the push catheter 14 may be attached to thehandle assembly 16. For example, the proximal end 32 may include afemale luer lock connector 34 threadably coupled to a threaded maleconnector 36 of the handle assembly 16. It is understood, however, thatthe push catheter 14 may be attached to the handle assembly 16 andextend distally therefrom by other means, such as adhesive bonding,welding, friction fit, interlocking fit, or other suitable means. Insome instances, a component of the push catheter 14 may belongitudinally (e.g., slidably and/or rotatably) actuatable relative toanother component of the push catheter 14. In such embodiments, thehandle assembly 16 may be configured such that the actuatable componentof the push catheter 14 may be actuated by medical personnel while thestationary component of the push catheter 14 remains stationary relativeto the handle assembly 16.

The guide catheter 12 may include a distal tubular portion 38 and aproximal elongate wire 40, such as a pull wire, coupled to the distaltubular portion 38. The elongate wire 40 may be coupled to the distaltubular portion 38 at a coupling location. The elongate wire 40 mayextend through the lumen 28 of the push catheter 14 to the handleassembly 16 while the distal tubular portion 38 extends through thedrainage stent 20 to a location distal of the drainage stent 20. In someembodiments, the elongate wire 40 may extend through the handle assembly16 to a location proximal of the handle assembly 16. The proximal end ofthe elongate wire 40 may terminate at a knob 42 which may be grasped byan operator to manipulate the guide catheter 12.

As shown in FIG. 2, the elongate wire 40 may share the lumen 28 of thepush catheter 14 with the guidewire 2 along a portion of the length ofthe elongate wire 40. Thus, a portion of the elongate wire 40 may extendproximally from the tubular portion 38 along the side of the guidewire 2through the lumen 28 of the push catheter 14 up to a location where theguidewire 2 exits the proximal guidewire port 26 of the push catheter14.

During a medical procedure, the drainage stent delivery system 10 may beadvanced to a target location in the anatomy of a patient. For instance,the drainage stent delivery system 10 may be advanced over the guidewire2 to a target location. In some instances, the drainage stent deliverysystem 10 may be tracked over the guidewire 2 as the drainage stentdelivery system 10 is advanced through a working channel of anendoscope. The guidewire 2 may pass through the lumen 22 of the guidecatheter 12 and the lumen 28 of the push catheter 14 and exit throughthe proximal guidewire port 26 of the push catheter 14.

When the drainage stent 20 has been positioned at the target location ina lumen, the operator may then selectively disengage the drainage stent20 from the drainage stent delivery system 10 and withdraw the drainagestent delivery system 10, or components thereof, proximally relative tothe drainage stent 20 to deploy the drainage stent 20 at the targetlocation. For instance, in some embodiments axial movement of anelongate shaft of the drainage stent delivery system 10 (e.g., the guidecatheter 12 and/or the push catheter 14) relative to the drainage stent20 may disengage or unlock the drainage stent 20 from the drainage stentdelivery system 10. Once the drainage stent 20 is disengaged from theguide catheter 12 and/or the push catheter 14, withdrawing the guidecatheter 12 and/or the push catheter 14 proximally may release thedrainage stent 20 from the drainage stent delivery system 10 in order todeploy the drainage stent 20 at the target location. Once the drainagestent 20 has been properly deployed at the target location, the drainagestent delivery system 10 may then be withdrawn. In some instances, thedrainage stent delivery system 10 may also be used to reposition and/orretrieve the drainage stent 20 during a medical procedure.

Some exemplary retention structures for selectively coupling thedrainage stent 20 to a component, such as an elongate shaft, of thedrainage stent delivery system 10 will now be further described.

FIGS. 3A and 3B illustrate the functionality of a first exemplaryretention structure for selectively coupling the drainage stent 20 to anelongate shaft of the drainage stent delivery system 10. Although thedrainage stent 20 is illustrated as being selectively coupled to theguide catheter 12 of the drainage stent delivery system 10, it isunderstood that in some embodiments the drainage stent 20 may beselectively coupled to the push catheter 14, or another elongate shaft,in the manner described with regard to FIGS. 3A and 3B.

FIG. 3A illustrates the drainage stent 20 positioned on and surroundingthe elongate shaft of the guide catheter 12 in which the drainage stent20 is retained on the guide catheter 12. As shown in FIG. 3A, a distalportion of the guide catheter 12 may extend distally from the distal end30 of the push catheter 14 into and/or through the lumen 48 of thedrainage stent 20 such that the distal end of the guide catheter 12 islocated distal of the proximal end 44 of the drainage stent 20.

The guide catheter 12 may include a portion configured to form aninterference fit with the drainage stent 20. For instance, the guidecatheter 12 may include an interference fit member 50 positioned on theelongate shaft of the guide catheter 12. The interference fit member 50may be configured to cooperate with the drainage stent 20 to form aninterference fit therebetween. In some instances, as shown in FIG. 3A,the interference fit member 50 may be a raised protuberance 52 extendingradially outward from the outer surface of the elongate shaft of theguide catheter 12. In some instances, the protuberance 52 may be anannular ridge extending circumferentially around the elongate shaft ofthe guide catheter 12. In other instances, the protuberance 52 may beone or more bumps, projections, bulges or other features extendingradially outward of the outer surface of the elongate shaft of the guidecatheter 12. The protuberance 52 may be a unitary portion of theelongate shaft of the guide catheter 12 or the protuberance 52 may be aseparate component secured to the elongate shaft of the guide catheter12.

The protuberance 52 may be configured to form an interference fit with aportion of the drainage stent 20 to selectively retain the drainagestent 20 on the guide catheter 12 until deployment of the drainage stent20 is desired. For example, the protuberance 52 may be configured to bein contact with an interior surface of the drainage stent 20, forming aninterference fit therebetween. As shown in FIG. 3A, the drainage stent20 may include a radially inward extending lip 60 at the proximal end 44of the drainage stent 20. The lip 60 may define an opening 62 into theinterior of the drainage stent 20 through which the guide catheter 12extends through. The opening 62 may have a diameter D2 which is lessthan the inner diameter of the more distal portion of the drainage stent20. The diameter D2 of the opening 62 may be less than the radial extentor diameter D1 of the protuberance 52, creating an interference fitbetween the protuberance 52 and the lip 60.

With the protuberance 52 on the elongate shaft of the guide catheter 12located in a first position, shown in FIG. 3A, in which the protuberance52 is positioned within the lumen 48 of the drainage stent 20, thedrainage stent 20 is secured to the guide catheter 12. The interferencefit between the protuberance 52 and the lip 60 prevents decoupling ofthe drainage stent 20 from the guide catheter 12 without applying athreshold amount of force to overcome the interference fit. In someinstances, the lip 60 of the drainage stent 20 may be interposed betweenthe distal end 30 of the push catheter 14 and the protuberance 52 on theguide catheter 12 when the drainage stent 20 is removably coupled to thedrainage stent delivery system 10.

The drainage stent 20 may be decoupled from the guide catheter 12through axial movement of the guide catheter 12 relative to the drainagestent 20 while the proximal end 44 of the drainage stent 20 abuts thedistal end 30 of the push catheter 14, holding the drainage stent 20stationary relative to the push catheter 14. For instance, as shown inFIG. 3B, axial or longitudinal movement of the guide catheter 12 in aproximal direction may move the protuberance 52 from the first positionin which the protuberance 52 is positioned within the lumen 48 of thedrainage stent 20 to a second position in which the protuberance 52 ispositioned exterior of the lumen 48 of the drainage stent 20, forexample, proximal of the drainage stent 20.

An axial force greater than a threshold level is necessary to deflectthe protuberance 52 and/or the lip 60 of the drainage stent 20 asufficient amount to allow the protuberance 52 to be pulled proximallyout through the opening 62 of the drainage stent 20. For instance, theprotuberance 52 and/or the lip 60 may be sized and configured such thatan axial force of less than 2 pounds applied to the guide catheter 12 isinsufficient to pull the protuberance 52 proximally through the opening62 of the drainage stent 20. The protuberance 52 and/or the lip 60 maybe sized and configured such that an axial force greater than 2 pounds,for example, an axial force of about 3 pounds to about 4 pounds, may besufficient to deflect the protuberance 52 and/or the lip 60 of thedrainage stent 20 to allow the protuberance 52 to be removed from theinterior of the drainage stent 20. The threshold level of force neededto withdraw the protuberance 52 from the lumen 48 of the drainage stent20, and thus decouple the drainage stent 20 from the guide catheter 12may be chosen depending on the medical application. For example, thethreshold level may be greater than resistance forces exerted on thedrainage stent 20 during normal positioning, repositioning and/orretrieval procedures. In some instances, the threshold level may be 2pounds, 3 pounds, 4 pounds or more depending on the level of retentiondesired.

Thus, axial force applied to the guide catheter 12 pushes the proximalend 44 of the drainage stent 20 into contact with the distal end 30 ofthe push catheter 14 as the protuberance 52 pushes against the distalside of the lip 60. When a sufficient axial force is applied, theprotuberance 52 is pulled through the opening 62 of the drainage stent20. Thus, the axial force applied to withdraw the guide catheter 12 fromthe drainage stent 20 must be sufficiently large to deflect theprotuberance 52 and/or the lip 60 sufficiently to allow the protuberance52 to pass through the opening 62.

FIGS. 4A and 4B illustrate the functionality of a second exemplaryretention structure for selectively coupling the drainage stent 20 to anelongate shaft of the drainage stent delivery system 10. Although thedrainage stent 20 is illustrated as being selectively coupled to theguide catheter 12 of the drainage stent delivery system 10, it isunderstood that in some embodiments the drainage stent 20 may beselectively coupled to the push catheter 14, or another elongate shaft,in the manner described with regard to FIGS. 4A and 4B.

FIG. 4A illustrates the drainage stent 20 positioned on and surroundingthe elongate shaft of the guide catheter 12 in which the drainage stent20 is retained on the guide catheter 12. As shown in FIG. 4A, a distalportion of the guide catheter 12 may extend distally from the distal end30 of the push catheter 14 into and/or through the lumen 48 of thedrainage stent 20 such that the distal end of the guide catheter 12 islocated distal of the proximal end 44 of the drainage stent 20.

The guide catheter 12 may include a portion configured to form aninterference fit with the drainage stent 20. For instance, the guidecatheter 12 may include an interference fit member 150 (or a pluralityof interference fit members) positioned on the elongate shaft of theguide catheter 12. The interference fit member 150 may be configured tocooperate with the drainage stent 20 to form an interference fittherebetween. In some instances, as shown in FIG. 4A, the interferencefit member 150 may be a raised protuberance 152, or a plurality ofraised protuberances 152, extending radially outward from the outersurface of the elongate shaft of the guide catheter 12. In someinstances, the protuberance(s) 152 may be an annular ridge extendingcircumferentially around the elongate shaft of the guide catheter 12. Inother instances, the protuberance(s) 152 may be one or more bumps,projections, bulges or other features extending radially outward of theouter surface of the elongate shaft of the guide catheter 12. Theprotuberance(s) 152 may be a unitary portion of the elongate shaft ofthe guide catheter 12 or the protuberance(s) 152 may be a separatecomponent secured to the elongate shaft of the guide catheter 12.

While further discussion will be directed to a protuberance 152 of theguide catheter 12, it is noted that the discussion may apply equality toeach protuberance 152 of the guide catheter 12. The protuberance 152 maybe configured to form an interference fit with a portion of the drainagestent 20 to selectively retain the drainage stent 20 on the guidecatheter 12 until deployment of the drainage stent 20 is desired. Forexample, the protuberance 152 may be configured to be in contact with aninterior surface 49 of the drainage stent 20, forming an interferencefit therebetween. For instance, the interference fit may be a frictionalfit between the surface of the protuberance 152 and the interior surface49 of the drainage stent 20 having a coefficient of static frictionsufficient to retain the drainage stent 20 on the guide catheter 12until deployment is desired.

With the protuberance 152 on the elongate shaft of the guide catheter 12located in a first position, shown in FIG. 4A, in which the protuberance152 is positioned within the lumen 48 of the drainage stent 20, thedrainage stent 20 is secured to the guide catheter 12. The interferencefrictional fit between the protuberance 152 and the interior surface 49of the drainage stent 20 prevents decoupling of the drainage stent 20from the guide catheter 12 without applying a threshold amount of forceto overcome the interference fit.

The drainage stent 20 may be decoupled from the guide catheter 12through axial movement of the guide catheter 12 relative to the drainagestent 20 while the proximal end 44 of the drainage stent 20 abuts thedistal end 30 of the push catheter 14, holding the drainage stent 20stationary relative to the push catheter 14. For instance, as shown inFIG. 4B, axial or longitudinal movement of the guide catheter 12 in aproximal direction may move the protuberance(s) 152 from the firstposition in which the protuberance(s) 152 is/are positioned within thelumen 48 of the drainage stent 20 to a second position in which theprotuberance(s) 152 is/are positioned exterior of the lumen 48 of thedrainage stent 20, for example, proximal of the drainage stent 20.

An axial force greater than a threshold level is necessary to overcomethe coefficient of static friction caused by the interference frictionalfit between the protuberance(s) 152 and the interior surface 49 of thedrainage stent 20 a sufficient amount to allow the protuberance(s) 152to be pulled proximally out of the lumen 48 of the drainage stent 20 toa position proximal of the drainage stent 20. For instance, theprotuberance(s) 152 may be sized and configured relative to the innerdiameter of the drainage stent 20 such that an axial force of less than2 pounds applied to the guide catheter 12 is insufficient to pull theprotuberance(s) 152 proximally from the lumen 48 of the drainage stent20. The protuberance(s) 152 may be sized and configured such that anaxial force greater than 2 pounds, for example, an axial force of about3 pounds to about 4 pounds, may be sufficient to overcome thecoefficient of static friction between the protuberance(s) 152 and theinterior surface 49 of the drainage stent 20 to allow theprotuberance(s) 152 to be removed from the interior of the drainagestent 20. The threshold level of force needed to withdraw theprotuberance(s) 152 from the lumen 48 of the drainage stent 20, and thusdecouple the drainage stent 20 from the guide catheter 12 may be chosendepending on the medical application. For example, the threshold levelmay be greater than resistance forces exerted on the drainage stent 20during normal positioning, repositioning and/or retrieval procedures. Insome instances, the threshold level may be 2 pounds, 3 pounds, 4 poundsor more depending on the level of retention desired.

Thus, axial force applied to the guide catheter 12 pushes the proximalend 44 of the drainage stent 20 into contact with the distal end 30 ofthe push catheter 14 as the protuberance(s) 152 is frictionally engagedand stationary with the drainage stent 20. When a sufficient axial forceis applied to overcome the static frictional force between theprotuberance(s) 152 and the drainage stent 20, the protuberance(s) 152is/are pulled proximally relative to the drainage stent 20 to a positionproximal of the drainage stent 20. Thus, the axial force applied towithdraw the guide catheter 12 from the drainage stent 20 must besufficiently large to overcome the static frictional forces caused bythe interference fit between the protuberance(s) 152 and the interiorsurface 49 of the drainage stent 20.

FIGS. 5A and 5B illustrate the functionality of another exemplaryretention structure for selectively coupling the drainage stent 20 to anelongate shaft of the drainage stent delivery system 10. Although thedrainage stent 20 is illustrated as being selectively coupled to theguide catheter 12 of the drainage stent delivery system 10, it isunderstood that in some embodiments the drainage stent 20 may beselectively coupled to the push catheter 14, or another elongate shaft,in the manner described with regard to FIGS. 5A and 5B.

FIG. 5A illustrates the drainage stent 20 positioned on and surroundingthe elongate shaft of the guide catheter 12 in which the drainage stent20 is retained on the guide catheter 12. As shown in FIG. 5A, a distalportion of the guide catheter 12 may extend distally from the distal end30 of the push catheter 14 into and/or through the lumen 48 of thedrainage stent 20 such that the distal end of the guide catheter 12 islocated distal of the proximal end 44 of the drainage stent 20.

The guide catheter 12 may include a portion configured to form aninterference fit with the drainage stent 20. For instance, the guidecatheter 12 may include an interference fit member 250 positioned on theelongate shaft of the guide catheter 12. The interference fit member 250may be configured to cooperate with the drainage stent 20 to form aninterference fit therebetween. In some instances, as shown in FIG. 5A,the interference fit member 250 may be an annular sleeve 252circumferentially surrounding the outer surface of the elongate shaft ofthe guide catheter 12. In some instances, the annular sleeve 252 may beformed of a polymeric foam material or other compressible material.

The annular sleeve 252 may be configured to form an interference fitwith a portion of the drainage stent 20 to selectively retain thedrainage stent 20 on the guide catheter 12 until deployment of thedrainage stent 20 is desired. For example, the annular sleeve 252 may beconfigured to be in contact with an interior surface 49 of the drainagestent 20, forming an interference fit therebetween. For instance, theinterference fit may be a frictional fit between the surface of theannular sleeve 252 and the interior surface 49 of the drainage stent 20having a coefficient of static friction sufficient to retain thedrainage stent 20 on the guide catheter 12 until deployment is desired.The annular sleeve 252, which may comprise a compressible material, suchas a polymeric foam, may be radially compressed when positioned in thelumen 48 of the drainage stent 20.

With the annular sleeve 252 on the elongate shaft of the guide catheter12 located in a first position, shown in FIG. 5A, in which the annularsleeve 252 is positioned within the lumen 48 of the drainage stent 20,the drainage stent 20 is secured to the guide catheter 12. Compressionof the annular sleeve 252 against the interior surface 49 of thedrainage stent 20 provides an interference frictional fit. Theinterference frictional fit between the annular sleeve 252 and theinterior surface 49 of the drainage stent 20 prevents decoupling of thedrainage stent 20 from the guide catheter 12 without applying athreshold amount of force to overcome the interference fit.

The drainage stent 20 may be decoupled from the guide catheter 12through axial movement of the guide catheter 12 relative to the drainagestent 20 while the proximal end 44 of the drainage stent 20 abuts thedistal end 30 of the push catheter 14, holding the drainage stent 20stationary relative to the push catheter 14. For instance, as shown inFIG. 5B, axial or longitudinal movement of the guide catheter 12 in aproximal direction may move the annular sleeve 252 from the firstposition in which the annular sleeve 252 is positioned within the lumen48 of the drainage stent 20 to a second position in which the annularsleeve 252 is positioned exterior of the lumen 48 of the drainage stent20, for example, proximal of the drainage stent 20.

An axial force greater than a threshold level is necessary to overcomethe coefficient of static friction caused by the interference frictionalfit between the annular sleeve 252 and the interior surface 49 of thedrainage stent 20 a sufficient amount to allow the annular sleeve 252 tobe pulled proximally out of the lumen 48 of the drainage stent 20 to aposition proximal of the drainage stent 20. For instance, the annularsleeve 252 may be sized and configured relative to the inner diameter ofthe drainage stent 20 such that an axial force of less than 2 poundsapplied to the guide catheter 12 is insufficient to pull the annularsleeve 252 proximally from the lumen 48 of the drainage stent 20. Theannular sleeve 252 may be sized and configured such that an axial forcegreater than 2 pounds, for example, an axial force of about 3 pounds toabout 4 pounds, may be sufficient to overcome the coefficient of staticfriction between the annular sleeve 252 and the interior surface 49 ofthe drainage stent 20 to allow the annular sleeve 252 to be removed fromthe interior of the drainage stent 20. The threshold level of forceneeded to withdraw the annular sleeve 252 from the lumen 48 of thedrainage stent 20, and thus decouple the drainage stent 20 from theguide catheter 12 may be chosen depending on the medical application.For example, the threshold level may be greater than resistance forcesexerted on the drainage stent 20 during normal positioning,repositioning and/or retrieval procedures. In some instances, thethreshold level may be 2 pounds, 3 pounds, 4 pounds or more depending onthe level of retention desired.

Thus, axial force applied to the guide catheter 12 pushes the proximalend 44 of the drainage stent 20 into contact with the distal end 30 ofthe push catheter 14 as the annular sleeve 252 is frictionally engagedand stationary with the drainage stent 20. When a sufficient axial forceis applied to overcome the static frictional force between the annularsleeve 252 and the drainage stent 20, the annular sleeve 252 is pulledproximally relative to the drainage stent 20 to a position proximal ofthe drainage stent 20. Thus, the axial force applied to withdraw theguide catheter 12 from the drainage stent 20 must be sufficiently largeto overcome the static frictional forces caused by the interference fitbetween the annular sleeve 252 and the interior surface 49 of thedrainage stent 20.

FIGS. 6A-6C illustrate the functionality of yet another exemplaryretention structure for selectively coupling the drainage stent 20 to anelongate shaft of the drainage stent delivery system 10. Although thedrainage stent 20 is illustrated as being selectively coupled to thepush catheter 14 of the drainage stent delivery system 10, it isunderstood that in some embodiments the drainage stent 20 may beselectively coupled to the guide catheter 12, or another elongate shaft,in the manner described with regard to FIGS. 6A-6C.

FIG. 6A illustrates a distal portion 352 of the push catheter 14positioned on and surrounding a proximal portion of the drainage stent20 to retain the drainage stent 20 to the drainage stent delivery system10. Thus, when coupled to the drainage stent 20, the distal end 30 ofthe push catheter 14 may be located distal of the proximal end 44 of thedrainage stent 20. Also shown in FIG. 6A, a distal portion of the guidecatheter 12 may extend distally from the distal end 30 of the pushcatheter 14 into and/or through the lumen 48 of the drainage stent 20such that the distal end of the guide catheter 12 is located distal ofthe proximal end 44 of the drainage stent 20.

The distal portion 352 of the push catheter 14 may be configured to forman interference fit with the drainage stent 20. For instance, the distalportion 352 of the push catheter 14 may be considered an interferencefit member 350 configured to cooperate with the drainage stent 20 toform an interference fit therebetween. In some instances, as shown inFIG. 6A, the distal portion 352 of the push catheter 14 maycircumferentially surround and be press fit against the outer surface ofthe proximal portion of the drainage stent 20, forming an interferencefit therebetween. The distal portion 352 forming the interference fitmember 350 may be a unitary portion of the elongate shaft of the pushcatheter 14, or the distal portion 352 may be a separate componentsecured to the elongate shaft of the push catheter 14.

The distal portion 352 may be configured to form an interference fitwith a proximal portion of the drainage stent 20 to selectively retainthe drainage stent 20 to the push catheter 14 until deployment of thedrainage stent 20 is desired. For example, the proximal portion of thedrainage stent 20 may be press fit into the distal portion 352 such thatthe outer surface of the drainage stent 20 presses against the interiorsurface of the distal portion 352, forming an interference fittherebetween. For instance, the interference fit may be a frictional fitbetween the interior surface of the distal portion 352 and the exteriorsurface of the drainage stent 20 having a coefficient of static frictionsufficient to retain the drainage stent 20 in the push catheter 14 untildeployment is desired. In some instances, the distal portion 352 of thepush catheter 14 may be radially compressed or crimped around theproximal portion of the drainage stent 20 by mechanical means to providea press fit between the distal portion 352 and the drainage stent 20. Insome embodiments, the outer diameter of the proximal portion of thedrainage stent 20 may be greater than the inner diameter of the distalportion 352 to create an interference fit therebetween.

In a first position, shown in FIG. 6A, in which the proximal portion ofthe drainage stent 20 is press fit within the distal portion 352 of thepush catheter 14, the drainage stent 20 is secured to the push catheter14. Compressive forces between the inner surface of the distal portion352 and the exterior surface of the drainage stent 20 provides aninterference frictional fit. The interference frictional fit between thedistal portion 352 and the drainage stent 20 prevents decoupling of thedrainage stent 20 from the push catheter 14 without applying a thresholdamount of force to overcome the interference fit.

The drainage stent 20 may be decoupled from the push catheter 14 throughaxial movement of the push catheter 14 relative to the drainage stent20. For instance, as shown in FIG. 6B, axial or longitudinal movement ofthe push catheter 14 in a proximal direction while holding the drainagestent 20 stationary may move the distal portion 352 from the firstposition in which the distal portion 352 surrounds the proximal portionof the drainage stent 20 to a second position in which the distalportion 352 is positioned proximal of the drainage stent 20.

As shown in FIG. 6B, the guide catheter 12 may be utilized to restrainthe drainage stent 20 from proximal movement as the push catheter 14 iswithdrawn proximally. For instance, the guide catheter 12 may include anannular rim or projection 354 which contacts the proximal end 44 of thedrainage stent 20. The guide catheter 12 may be held stationary as thepush catheter 14 is actuated proximally, thereby preventing the drainagestent 20, abutting the annular rim 354 of the guide catheter 12, frommoving proximally with the push catheter 14. Alternatively, the guidecatheter 12 may be actuated distally while holding the push catheter 14stationary to expel the proximal portion of the drainage stent 20distally from the distal portion 352 of the push catheter 14.

An axial force greater than a threshold level is necessary to overcomethe coefficient of static friction caused by the interference frictionalfit between the distal portion 352 of the push catheter 14 and theexterior surface of the drainage stent 20 a sufficient amount to allowthe proximal portion of the drainage stent 20 to be decoupled from thelumen of the distal portion 352 of the push catheter 14. For instance,the distal portion 352 may be sized and configured relative to the outerdiameter of the drainage stent 20 such that an axial force of less than2 pounds applied to the push catheter 14 is insufficient to pull thedistal portion 352 proximally from the engagement with the drainagestent 20. The distal portion 352 may be sized and configured such thatan axial force greater than 2 pounds, for example, an axial force ofabout 3 pounds to about 4 pounds, may be sufficient to overcome thecoefficient of static friction between the distal portion 352 and theexterior surface of the drainage stent 20 to allow the proximal portionof the drainage stent 20 to be removed from the interior of the distalportion 352 of the push catheter 14. The threshold level of force neededto withdraw the push catheter 14 from the drainage stent 20, and thusdecouple the drainage stent 20 from the push catheter 14 may be chosendepending on the medical application. For example, the threshold levelmay be greater than resistance forces exerted on the drainage stent 20during normal positioning, repositioning and/or retrieval procedures. Insome instances, the threshold level may be 2 pounds, 3 pounds, 4 poundsor more depending on the level of retention desired.

Thus, axial force applied to the push catheter 14 pulls the proximal end44 of the drainage stent 20 into contact with the annular rim 354 of theguide catheter 12 as the distal portion 352 is frictionally engaged andstationary with the drainage stent 20. When a sufficient axial force isapplied to overcome the static frictional force between the distalportion 352 of the push catheter 14 and the drainage stent 20, thedistal portion 352 of the push catheter 14 is pulled proximally relativeto the drainage stent 20 to a position proximal of the drainage stent20. Thus, the axial force applied to withdraw the push catheter 14 fromthe drainage stent 20 must be sufficiently large to overcome the staticfrictional forces caused by the interference fit between the distalportion 352 and the exterior surface of the drainage stent 20.

As shown in FIG. 6C, once the drainage stent 20 has been decoupled fromthe distal portion 352 of the push catheter 14, the guide catheter 12can be withdrawn proximally from the lumen 48 of the drainage stent 20to deploy the drainage stent 20 at a desired anatomical location. Thepush catheter 14 may also be withdrawn further proximally simultaneouslyor consecutively with the guide catheter 12.

FIG. 7A illustrates another embodiment of an interference fit member 450in accordance with this disclosure. It is noted that the configurationof the interference fit member 450 may be incorporated into any one ofthe other embodiments disclosed herein. The interference fit member 450,located on a distal portion of the guide catheter 12, may be configuredto engage the inner surface of the drainage stent 20 to secure thedrainage stent 20 on the guide catheter 12.

The interference fit member 450 may include one or more elongate members452. In some instances, the elongate member 452 may be an annular sleevesurrounding the guide catheter 12. In other instances, one or moreelongate members 452 may be located at discrete positions around thecircumference of the guide catheter 12 such the elongate members 452 arediscontinuous with one another. The elongate member(s) 452 may have adistal end 454 extending a first height H1 (e.g. radially outward) fromthe outer surface of the guide catheter 12 and a proximal end 456extending a second height H2 (e.g., radially outward) from the outersurface of the guide catheter 12. The first height H1 may be greaterthan the second height H2 such that the outer extent of the elongatemember(s) 452 tapers relative to the central longitudinal axis of theguide catheter 12. Such a configuration may facilitate removal of theinterference fit member 450 from within the drainage stent 20.

In other embodiments, the proximal end of the elongate member 452 mayextend radially outward from the outer surface of the guide catheter 12less than the distal end of the elongate member 452. Such aconfiguration may facilitate inserting the interference fit member 450into the lumen of the drainage stent 20, to load the drainage stent 20on the delivery system.

FIG. 7B illustrates an embodiment of an interference fit member 550 inaccordance with this disclosure. It is noted that the configuration ofthe interference fit member 550 may be incorporated into any one of theother embodiments disclosed herein. The interference fit member 550,located on a distal portion of the guide catheter 12, may be configuredto engage the inner surface 49 of the drainage stent 20 to secure thedrainage stent 20 on the guide catheter 12.

The interference fit member 550 may be an annular membercircumferentially surrounding the guide catheter 12. Thus, theinterference fit member 550 may engage the inner surface 49 of thedrainage stent 20 along substantially the entire or the entirecircumference of the inner surface 49 of the drainage stent 20.

FIG. 7C illustrates an embodiment of an interference fit member 650 inaccordance with this disclosure. It is noted that the configuration ofthe interference fit member 650 may be incorporated into any one of theother embodiments disclosed herein. The interference fit member 650,located on a distal portion of the guide catheter 12, may be configuredto engage the inner surface 49 of the drainage stent 20 to secure thedrainage stent 20 on the guide catheter 12.

The interference fit member 650 may be one or more discrete and/ordiscontinuous members 652 positioned symmetrically or asymmetricallyaround the circumference of the guide catheter 12 and extending radiallyoutward therefrom. Thus, the interference fit member 650 may engage theinner surface 49 of the drainage stent 20 at one or more discretecontact locations around the circumference of the inner surface 49 ofthe drainage stent 20.

FIG. 7D illustrates an embodiment of an interference fit member 750 inaccordance with this disclosure. It is noted that the configuration ofthe interference fit member 750 may be incorporated into any one of theother embodiments disclosed herein. The interference fit member 750,located on a distal portion of the guide catheter 12, may be configuredto engage the inner surface 49 of the drainage stent 20 to secure thedrainage stent 20 on the guide catheter 12.

The interference fit member 750 may be a non-circular or polygonalshaped member 752 having one or more portions extending radially outwardfrom the central longitudinal axis of the guide catheter 12 further thanother portions of the member 752. For example, as shown in FIG. 7D, themember 752 may have four corners which extend further radially outwardthan other portions of the member 752. In other instances, the member752 may have 1, 2, 3, 4, 5, 6, 7, 8 or more corners or edges whichextend further radially outward than other portions of the member 752.Thus, the interference fit member 750 may engage the inner surface 49 ofthe drainage stent 20 at one or more discrete contact locations (e.g.,at the corners or edges) around the circumference of the inner surface49 of the drainage stent 20.

In any of the embodiments disclosed herein, the interference fit membermay include a coating or layer to increase friction between theinterference fit member and the drainage stent 20 and/or the engagingsurface of the interference fit member may be modified to increasefriction between the interference fit member and the drainage stent 20.For instance, the interference fit member may include a sticky or tackycoating, a silicone layer, knurlings, bumps, grooves, ridges, surfaceroughenings, etc., to increase the friction between the interference fitmember and the drainage stent 20.

In any of the embodiments disclosed herein, the interference fit membermay include a coating and/or be formed of a material which becomes morelubricious when wetted with a fluid. For example, when deployment of thedrainage stent 20 is desired, a fluid may be injected through thedrainage stent delivery system 10 or through another medical device toreduce the friction between the interference fit member and the drainagestent 20 to facilitate removal of the drainage stent 20 from theinterference fit member. Such a fluid may increase the lubricity of thecoating and/or material and thus reduce the coefficient of frictionbetween the interference fit member and the drainage stent 20. In someinstances regardless of whether such a coating and/or material is used,it still may be desirable to inject a fluid through the drainage stentdelivery system 10 or through another medical device during deploymentof the drainage stent 20 to facilitate disengagement of the drainagestent 20 from the interference fit member.

In any of the embodiments disclosed herein, the interference fit membermay include cuts and/or gaps in the interference fit member whichfacilitate removal of the interference fit member from the drainagestent 20. For example, such cuts and/or gaps may enhance the flexibilityof the interference fit member to deflect, compress, elongate, orotherwise deform as the interference fit member is removed form thedrainage stent 20.

Although several illustrated embodiments of the disclosed stentretention structures are illustrated as being incorporated into adelivery system for delivering a drainage stent, it is understood thatthe stent retention structures may also be used to selectively coupleother stent or endoprosthesis devices to a delivery system. For example,in some instances the stent retention structures described herein may beused to selectively couple a vascular stent to an elongate member of adelivery system for delivering the vascular stent to a target locationwithin the vasculature of a patient.

Those skilled in the art will recognize that the present invention maybe manifested in a variety of forms other than the specific embodimentsdescribed and contemplated herein. Accordingly, departure in form anddetail may be made without departing from the scope and spirit of thepresent invention as described in the appended claims.

What is claimed is:
 1. A stent delivery system comprising: an elongateshaft of a medical device, the elongate shaft having a proximal end anda distal end; a non-expandable tubular stent having a proximal end, adistal end, and a lumen extending therethrough, the lumen being definedby an inner surface of the tubular stent, the tubular stent positionedon and surrounding a distal portion of the elongate shaft; and aninterference fit member positioned on and axially fixed at a pluralityof axially spaced apart points relative to the elongate shaft andmovable therewith, the interference fit member configured to cooperatewith the inner surface of the tubular stent to form an interference fittherebetween; wherein axial movement of the elongate shaft relative tothe tubular stent moves the interference fit member from a firstposition in which the interference fit member is positioned within thelumen of the tubular stent and forms an interference fit with the innersurface of the tubular stent to retain the tubular stent on the elongateshaft during delivery of the tubular stent to a target site to a secondposition in which the interference fit member is positioned exterior ofthe lumen of the tubular stent to release the tubular stent from theelongate shaft.
 2. The stent delivery system of claim 1, wherein theinterference fit member is a raised protuberance on the elongate shaft.3. The stent delivery system of claim 2, wherein the raised protuberanceforms an interference fit with an interior surface of the tubular stent.4. The stent delivery system of claim 2, wherein the raised protuberanceforms an interference fit with a radially inward extending lip at theproximal end of the tubular stent.
 5. The stent delivery system of claim4, wherein the proximal end of the tubular stent has an opening forreceiving the elongate shaft therethrough, the opening having adiameter, wherein the raised protuberance has a diameter greater thanthe diameter of the opening.
 6. The stent delivery system of claim 1,wherein the interference fit member is an annular sleeve surrounding theelongate shaft.
 7. The stent delivery system of claim 6, wherein theannular sleeve comprises a foam material.
 8. The stent delivery systemof claim 7, wherein the annular sleeve frictionally engages an interiorsurface of the tubular stent.
 9. The stent delivery system of claim 7,wherein the annular sleeve is compressed against an interior surface ofthe tubular stent.
 10. A drainage stent delivery system comprising: adrainage stent including a generally non-expandable tubular memberhaving a proximal end, a distal end and a central longitudinal axis; andan elongate shaft extending distally from a handle assembly through thedrainage stent to a location distal of the proximal end of the drainagestent, the elongate shaft including a portion fixed to the elongateshaft at a proximal end of the portion and at a distal end of theportion, the portion configured to form an interference fit with aninterior surface of the drainage stent to retain the drainage stent onthe elongate shaft during delivery of the tubular stent to a targetsite, the interference fit providing a static frictional force betweenthe portion of the elongate shaft and the interior surface of thedrainage stent sufficient to prevent decoupling the drainage stent fromthe elongate shaft; wherein the elongate shaft is longitudinallymoveable relative to the drainage stent by application of a thresholdamount of axial force to overcome the static frictional force to effectdisengagement of the drainage stent from the portion of the elongateshaft configured to form an interference fit with the drainage stent.11. The drainage stent delivery system of claim 10, wherein the portionof the elongate shaft configured to form an interference fit with thedrainage stent is a raised protuberance on the elongate shaft.
 12. Thedrainage stent delivery system of claim 11, wherein the raisedprotuberance forms an interference fit with a radially inward extendinglip at the proximal end of the drainage stent.